Installation body for body fluid sampling apparatus and method of manufacturing the apparatus

ABSTRACT

The present invention relates to an attachment (X) for body fluid sampling device, comprising: a lancing member ( 21 ) including a lancing needle ( 28 ); an analyzing implement ( 5 ) for obtaining information on a target component in body fluid; and an attachment main body ( 1 ) holding the lancing member ( 21 ) and the analyzing implement ( 5 ). The attachment main body (X) includes a movable member ( 3 ) movable with the analyzing implement ( 5 ) longitudinally of the lancing needle ( 28 ). The attachment main body ( 1 ) includes for example, a holder ( 2 ) for holding the lancing member ( 21 ). The holder ( 2 ) has an inner space ( 22 ) for movement of the lancing needle ( 28 ). The lancing needle ( 28 ) is held preferably as sealed in the inner space ( 22 ).

TECHNICAL FIELD

[0001] The present invention relates to an attachment to a body fluidsampling device, and a method of making the same. In particular, thepresent invention relates to an attachment suitable to a body fluidsampling device capable of measuring the concentration of a targetcomponent.

BACKGROUND ART

[0002] When treating diabetes, it is important to control the patient'sblood sugar level within the normal range, and so it is important thatthe patient has a control on his own blood sugar level. Especially forinsulin-dependent patients, it is essential to check their blood sugarlevel regularly in their daily life in order to maintain the blood sugarlevel within the normal range. Since it is inconvenient to make frequentvisit to a medical institute for the blood sugar measurement, portableblood sugar level testers are used so that the blood sugar level can bemeasured without the burden of visiting medical institutes.

[0003] An example of the portable blood sugar level tester is shown inFIG. 12 of the present application. This blood sugar level tester 8 usesan attachment 7. The attachment 7 includes a main body 70, whichincludes, integrally therewith, a lancing member 71 and a biosensor 72.The main body 70 has a housing space 73 for housing the lancing member71. The housing space 73 has an opening 74, which is closed by thebiosensor 72. The biosensor 72 provides an enzyme reaction field, andincludes a layer of reagent containing an enzyme and an electrontransfer material. The biosensor 72 is formed with a through hole forinsertion of a lancing member 75 of the lancing member 71.

[0004] If the blood has to be sampled from a region which does not bleedeasily, the blood sugar level tester 8 can be used to massage the targetarea Sk for improved blood flow, or the blood sugar level tester 8 canbe used to press the target area Sk. Instead, the area may be sucked tocause blood congestion, or treated in different ways to promote bleedingfrom the target area Sk. In these actions, the target area Sk tends tobulge as shown in an imaginary line in the drawing, yet if the biosensor72 is fixed on, the target area Sk is pressed onto the biosensor 72, andthus the target area Sk cannot bulge, leading to insufficient bleeding.If bleeding is insufficient, the biosensor cannot be supplied with asufficient amount of blood necessary for the blood sugar levelmeasurement, which can lead to an unacceptably large error in themeasurement, or a process error in measuring steps. On the contrary,some parts of the human body may not bulge very much, and bulging of theskin varies from person to person. Under these conditions, there can bea case where the biosensor does not touch the skin at the time oflancing.

[0005] According to the attachment 7, the lancing needle 75 is exposedwhether or not the biosensor 72 is integrated therewith. However, inview of sanitation on the lancing needle 75, the lancing needle 75 needsto be sterilized, and in order to prevent contamination after thesterilization, the lancing needle 75 must be sterilized as sealed in aspace, and the sealing must be maintained till the time of use. Now, inorder for the lancing needle 75 to be kept appropriately sterilized, theattachment 7 must be sealed with an aluminum laminate seal for examplewhile the lancing member 71 and the biosensor 72 must be integrated intothe main body 70. This is not possible for the attachment 7 in FIG. 12.Specifically, the lancing needle 75 cannot be sterilized separately fromthe biosensor 72 or from the enzyme contained in the biosensor 72.

[0006] The sterilization of the lancing needle 75 is made with gammarays for example. Existence of an enzyme during the sterilizationprocess, therefore, means that the enzyme will be destroyed or enzymeactivity will be reduced. If such happens, a longer time will berequired for the measurement, or the measured concentration can be lowerthan real, and in fact it becomes impossible to make appropriatemeasurement.

[0007] There is another problem: If the electron transfer material isprovided by potassium ferricyanide, the gamma ray radiation reduces thepotassium ferricyanide to potassium ferrocyanide. This is problematic ifan amperometric method is used in the measurement of oxidation current,because part of the electron transfer material in the chemically reducedstate is derived by the gamma ray radiation at the time of sterilizationwhile the rest being derived from the enzyme reaction. Accordingly, whenthe electron transfer material in the chemically reduced state isoxidized by a voltage, a measured value of the oxidation current will begreater, which will give a concentration measurement higher than thereal value, i.e. measuring accuracy will be low.

DISCLOSURE OF THE INVENTION

[0008] An object of the present invention is to provide an attachmentwhich does not hinder operations for promoted bleeding from a point oflancing, clears problems associated with sterilization of the lancingneedle, and is capable of performing appropriate measurement ofconcentration.

[0009] A first aspect of the present invention provides an attachmentfor body fluid sampling device, comprising: a lancing member including alancing needle; an analyzing implement for obtaining information on atarget component in body fluid; and an attachment main body holding thelancing member and the analyzing implement. The attachment main bodyincludes a movable member movable with the analyzing implementlongitudinally of the lancing needle.

[0010] The attachment main body includes, for example, a holder forholding the lancing member. In this case, the holder has an inner spacefor movement of the lancing member, and the lancing needle is held assealed in the inner space.

[0011] The holder includes, for example, an opening for the inner spaceto communicate with outside. In this case, the inner space is sealed bya seal on the opening. Alternatively, the sealing of the inner space maybe achieved by closing the opening with the movable member which isfixed with respect to the holder. On the other hand, the movable membermay be moved relatively to the holder when lancing, thereby breaking thesealing.

[0012] The attachment according to the present invention furthercomprises, preferably, a cap co-holding the analyzing implement with themovable member. In this case, removal of the cap leaves the analyzingimplement held by the movable member.

[0013] The movable member includes for example, first holding means forholding the analyzing implement whereas the cap includes second holdingmeans for holding the analyzing implement. In this case, the firstholding means has a greater holding force for holding the analyzingimplement than the second holding means.

[0014] The first holding means has a plurality of hook-like engagers.The second holding means includes for example, an engager having adiameter grater than that of the though hole, for insertion through thethrough hole.

[0015] The analyzing implement includes for example, a substrate, and afirst and a second electrodes formed on the substrate. In this case,preferably, the analyzing implement is held by the movable member, withpart of the first and the second electrodes extending sideways of themovable member.

[0016] The lancing member is preferably integral with the holder via aweak portion. In this case, the lancing member moves relatively to theholder upon a longitudinal load onto the lancing member.

[0017] A second aspect of the present invention provides a method ofmaking an attachment for body fluid sampling device, comprising: asealing step of sealing a lancing needle held by an attachment mainbody; a sterilizing step of sterilizing the attachment main body whichholds the lancing needle; and an analyzing implement mounting step ofmounting an analyzing implement in the sterilized attachment main body.

[0018] The analyzing implement mounting step is preferably performed byattaching a cap which holds the analyzing implement to the attachmentmain body. The cap may not be used of course, to have the analyzingimplement held by the attachment main body.

[0019] The attachment main body includes an inner space communicatingwith outside via an opening. In this case, the sealing step is performedby sealing the opening with a seal.

[0020] In the sealing step, the seal is fixed to the attachment mainbody by ultrasonic fusing.

[0021] The sealing step may include formation of a holder holding thelancing needle, and integration thereafter of the holder with a movablemember which has holding means for holding the analyzing implement andis movable back and forth relatively to the holder. Alternatively, theanalyzing implement may be held by the movable member, and the mountingof the analyzing implement in the attachment main body may be performedby attaching the movable member to the holder. In this case, theintegration of the holder with the movable member does not constitutepart of the sealing step, and is performed as a separate step from thesealing step.

BRIEF DESCRIPTION OF THE DRAWINGS

[0022]FIG. 1 is an exploded perspective view of an attachment accordingto the present invention.

[0023]FIGS. 2A and 2B are longitudinal sections of the attachment inFIG. 1.

[0024]FIG. 3 is a sectional view for describing how a movable memberworks in the attachment in FIG. 1.

[0025]FIGS. 4A and 4B are enlarged views of primary portions of theattachment in FIG. 1.

[0026]FIG. 5 is an overall perspective view of a biosensor used in theattachment in FIG. 1.

[0027]FIG. 6 is an exploded perspective view of the biosensor in FIG. 5.

[0028]FIGS. 7A through 7C are sectional views for describing a method ofmaking the attachment in FIG. 1.

[0029]FIG. 8 is a fragmentary sectional view, showing a primary portionof the attachment in FIG. 1 as attached to a body fluid sampling device.

[0030]FIG. 9 is a sectional view taken in lines IX-IX in FIG. 8.

[0031]FIGS. 10A through 10D are sectional views for describing a lancingaction by the body fluid sampling device and the attachment.

[0032]FIG. 11 is an enlarged view, showing a primary portion of the bodyfluid sampling device under a lancing state.

[0033]FIG. 12 is a sectional view showing a primary portion of a bloodsugar level tester incorporating a conventional attachment.

BEST MODE FOR CARRYING OUT THE INVENTION

[0034] Hereinafter, an example of the attachment for body fluid samplingdevice according the present invention will be described with referenceto attached drawings. FIG. 1 is an exploded perspective view of anattachment according to the present invention. FIG. 2 shows longitudinalsections of the attachment in FIG. 1.

[0035] As shown in FIG. 1 and FIG. 2, an attachment X includes: anattachment main body 1 having a holder 2 and a movable member 3; a cap4; a lancing member 21; and a biosensor 5.

[0036] The holder 2 includes a tubular main body 20 which provides aninner space 22. The main body 20 holds the lancing member 21. The mainbody 20 has a lower circumferential surface formed with a pair offlanges 23 and a pair of guide recesses 24. The flanges 23 arecircumferential whilst the guide recesses 24 are longitudinal. The innerspace 22 communicates with the outside via an opening 25. The opening 25is sealed with a seal 26.

[0037] The lancing member 21, on the other hand, includes a holder 27and a lancing needle 28. The lancing needle 28 has its tip extendingfrom the holder 27. The lancing member 21 further includes a brim 29extending radially outward. The brim 29 is provided all around thelancing member 21. The lancing member 21 is integral with the main body20 via the brim 29. The connection between the brim 29 and the main body20 is provided by a thin wall, so that when the lancing member 21 comesunder a load exceeding a predetermined level, the lancing member 21detaches from the main body 20. Since the brim 29 is all around thelancing member 21 and the opening 25 of the inner space 22 is sealed,the lancing needle 28 is sealed in. Alternatively however, the lancingmember 21 may be formed as a separate member from the main body 20.

[0038] The movable member 3 includes a main body 30, and a pair ofengaging tabs 31 extending upward therefrom. The engaging tabs 31 matewith the guiding recesses 24 of the holder 2. The engaging tabs 31 eachhave an upper tip formed with an engaging pawl 32. The engaging pawl 32engages with the corresponding one of the guiding recesses 24, and ismovable therein. As a result, as shown in FIG. 3, the movable member 3can move relatively to the holder 2 in vertical directions.

[0039] As shown in. FIG. 1 and FIG. 2, the main body 30 of the movablemember 3 includes a tubular portion 33 and a sensor attaching seat 34.The sensor attaching seat 34 has a flat upper surface 35. When theholder 2 is approached most closely by the movable member 3, the holder2 has its lower end contacting to the upper surface 35 of the sensorattaching seat 34 via the seal 26.

[0040] The sensor attaching seat 34 has a lower surface 36 formed with amounting surface 36 a to which a sensor 5 to be described later (SeeFIG. 5 and FIG. 6) is attached. The mounting surface 36 a is slantedwith respect to the upper surface 35 of the sensor attaching seat 34. Asshown in FIG. 3 and FIG. 4A, the mounting surface 36 a is formed withtwo pairs of engagers 37. The engagers 37 hold the biosensor 5 to themovable member 3. As shown clearly in FIG. 1 and FIG. 2B, the biosensor5 has its two ends extending from the movable member 3 when attached tothe mounting surface 36 a. Correspondingly, the movable member 3 isformed with cutouts 38 as shown clearly in FIG. 1.

[0041] The sensor attaching seat 34 has a center region formed with athrough hole 39. When the lancing member 21 moves down, the lancingneedle 28 goes through the through hole 39, with the tip of the lancingneedle 28 projecting out of the lower surface 36 of the sensor attachingseat 34. The through hole 39 has a diameter smaller than that of theholder 27. Thus, when the lancing member 21 moves down, the tip of theholder 27 interferes with the upper surface 35 of the sensor attachingseat 34 via the seal 26, limiting the movement of the lancing member 21.As a result, the amount of projection of the lancing needle 28 isconstant.

[0042] As shown in FIG. 1 and FIG. 2, the cap 4 includes a tubular mainbody 40 with an open upper end, and a pair of engaging tabs 41 extendingupward from the main body 40. The engaging tabs 41 each have a tipformed with an engager 42. As clearly shown in FIG. 2A, the engagers 42are mated with the flanges 23 of the holder 2. By engaging the engagers42 with the flanges 23, the cap 4 is attached to the attachment mainbody 1 to cover the movable member 3. In this sate, as clearly shown inFIG. 2B, the distance between the holder 2 and the movable member 3 isthe smallest.

[0043] As shown in FIG. 1 and FIG. 2A, the main body 40 of the cap 4 hasa bottom surface from which a pedestal 43 stands out upwardly. Thepedestal 43 holds the biosensor 5. As clearly shown in FIG. 4B, thepedestal 43 has an upper surface 43 a which is slanted at an anglematched to the mounting surface 36 a of the movable member 3. Also, asshown in this figure and in FIG. 1 the upper surface 43 a of thepedestal 43 is formed with a pair of engagers 44. As clearly shown inFIG. 4B, these engagers 44 and the through holes in the biosensor 5 (SeeFIG. 5 and FIG. 6.) secure the biosensor 5 on the pedestal 43. Thebiosensor 5 is also held by the movable member 3, and the holding forceby the cap 4 is smaller than the holding force by the movable member 3.Therefore, when the cap 4 is removed from the attachment main body 1,the biosensor 5 remains held by the movable member 3, and the biosensor5 is removed from the cap 4. As shown clearly in FIG. 1 and FIG. 2B, thebiosensor 5 has its two ends extending out of the cap 4 when held on thepedestal 43. Corresponding to this, the cap 4 is formed with cutouts 45as clearly shown in FIG. 1.

[0044] A biosensor 5 has, for example, a structure shown in FIG. 5 andFIG. 6. This biosensor 5 includes a substrate 50, a pair of spacers 51and a cover 52.

[0045] The substrate 50 is made of an insulating member, and in arectangular shape. The substrate 50 is formed with a cutout 53. Thesubstrate 50 has a surface 54 formed with a reaction electrode 55, apairing electrode 56 and a reagent layer 57. The reaction electrode 55and the pairing electrode 56 each extend from a shorter edge of thesubstrate 50 toward a center region of the substrate 50, with a portionat the center region being narrower. The reagent layer 57 is like a beltlaid across the reaction electrode 55 and the pairing electrode 56. Thereagent layer 57 is solid, containing an oxidation-reduction enzymeprovided by glucose dehydrogenase for example, and an electron transfermaterial provided by potassium ferricyanide for example.

[0046] The spacers 51 are rectangular, with a length equal to the widthof the substrate 50, and with a corner formed with an arcuate cutout 58.These spacers 51 are respectively placed on two sides of the reagentlayer 57, in parallel to each other and spaced by a distance equal tothe width of the reagent layer 57.

[0047] The cover 52 is rectangular, with a length equal to the width ofthe substrate 50, with one of the ends formed with an arcuate cutout 59.The cover 52 has the cutout 59 aligned with the cutout 53 of thesubstrate 50, and is fixed on the pair of spacers 51 to bridge thesespacers 51.

[0048] According to the biosensor 5, each of the substrate 50, thespacers 51 and the cover 52 is formed with a cutout 53, 58 or 59. Thesecutouts form a recess 5A, which is like a halved tube, through thethickness and opening in a direction along the width of the substrate50. As will be described later, the recess 5A serves as a receiver ofblood bled from the skin. Further, according to the biosensor 5, thesubstrate 50, the spacers 51 and the cover 52 collectively form achannel 5B across the width of the substrate 50. The channel 5B has anend communicating with the outside via the recess 5A, and another endcommunicating with the outside. Therefore, when the blood is introducedfrom the recess 5A, the capillarity makes the blood move through thechannel toward the other end. Since there is the reagent layer 57 in thechannel 5B, the blood moving through the channel 5B dissolves thereagent layer 57. During this, glucose contained in the blood isoxidized in an enzyme reaction, and electrons released in this reactionreduce the electron transfer material.

[0049] The attachment X as described above can be manufactured in thesteps to be described here below. It should be noted that formation isalready made for a holder 2, a movable member 3 and a cap 4, by means ofresin injection molding. Note further that the holder 2 is provided witha lancing member 21 integrally therewith, and a biosensor 5 is alreadyprepared.

[0050] First, as shown in FIG. 7A, the opening 25 of the holder 2 issealed with a seal 26. This achieves that the lancing needle 28 is heldunder a sealed condition. The seal 26 can be provided by a metal foilsuch as aluminum foil or a resin sheet. The seal 26 is fixed to theholder 2 by ultrasonic fusing for example. Then, with the lancing needle28 held under the sealed condition, the lancing needle 28 is sterilizedtogether with the holder 2. The sterilization can be performed by gammaray radiation for example.

[0051] Next, as shown in FIG. 7B, the movable member 3 is attached tothe holder 2, to make an attachment main body 1. The attaching of themovable member 3 is achieved by engaging the engaging pawls 32 of themovable member 3 with the guiding recesses 24 of the holder 2. At thisstage, the biosensor 5 is not yet fixed to the movable member 3.

[0052] Then, as shown in FIG. 7C, the cap 4 which holds the biosensor 5is attached to the attachment main body 1, whereby an attachment X asshown in FIG. 2 and other drawings is completed. It should be noted thatthe attaching of the biosensor 5 to the cap 4 is achieved as shown inFIG. 4B; i.e. the engagers 44 of the cap 4 are inserted throughrespective through holes 5′ and snapped around the through holes. On theother hand, the cap 4 is attached, as shown in FIG. 7C; i.e. theengagers 42 of the cap 4 are engaged with the flanges 23 of the holder2. Once the cap 4 has been attached to the attachment main body 1, asclearly shown in FIG. 2B, the tip of the holder 2 contacts the uppersurface 35 of the sensor attaching seat 34 of the movable member 3 viathe seal 26, whereas the tip of the movable member 3 contacts the bottomsurface of the main body 40 of the cap 4. In other words, the holder 2and the cap 4 sandwich the movable member 3. As a result, the biosensor5 is pressed against the mounting surface 36 a of the movable member 3,and as shown in FIG. 4A, the biosensor 5 is held in the engagers 37 ofthe movable member 3.

[0053] According to a method such as the above, when making theattachment X, the lancing needle 28 is sterilized separately from thebiosensor 5. Therefore, the sterilization process does not alter ordestroy the oxidation-reduction enzyme, nor chemically reduce theelectron transfer material contained in the reagent layer 57 of thebiosensor 5. Therefore, measuring accuracy is not affected by thesterilization process of the lancing needle 28.

[0054] Since the lancing needle 28 is sterilized under a sealedcondition, the lancing needle 28 is protected from contamination byfungi for example until the sealing is broken (till the time of use).

[0055] The biosensor 2 is held against the movable member 3 can beachieved by a simple operation such as attaching the cap 4 onto theattachment main body 1, resulting in good operability.

[0056] As shown in FIG. 8 and FIG. 9, the attachment X is used asattached to a tip 60 of a body fluid sampling device Y. As fitted to thetip 60 of the body fluid sampling device Y, the holder 3 of theattachment X is contacted to the flanges 64 a, 64 b on an inner surfaceof the tip 60 of the body fluid sampling device Y. Since the mounting ofthe attachment X is made by fitting the holder 2 onto the flanges 64 a,64 b of the body fluid sampling device Y, there is a gap between themovable member 3 and the tip 60, which allows relative vertical movementof the movable member 3 with respect to the tip of the body fluidsampling device Y. As will be expected from FIG. 8, when the movablemember 3 comes to its lowest position, the tip of the movable member 3projects out of the tip of the body fluid sampling device Y, whereas themovable member 3 is completely housed into the tip 60 of the body fluidsampling device Y when the movable member 3 comes to its highestposition.

[0057] When lancing operation is made, the cap 4 is removed. The cap 4maybe removed after the attachment X is attached to the body fluidsampling device Y, or the cap 4 may be removed before the attachmentmain body 1 is attached to the body fluid sampling device Y. In anycase, the cap can remain on the movable member 3 till the moment oflancing operation, and thus the biosensor 5 can be protected by the cap4 till the moment of lancing operation.

[0058] The body fluid sampling device Y includes a pair of connectorpins 61 extending downward. These connector pins 61 are held inrespective holders 62, and are urged downward for vertical movement, byrespective coils (not illustrated) placed in the holders 62. As shown inFIG. 8 and FIG. 9, the holders 62 are fixed at the flange 64 a of thebody fluid sampling device Y. This flange 64 a is also used for fittingthe holder 2 of the attachment X. Once the attachment X (the holder 2)is fitted to the body fluid sampling device Y, there is a gap 65 betweenthe attachment X (the holder 2) and an inner surface of the tip 60 ofthe body fluid sampling device Y. The gap 65 communicates with theoutside. The gap 65 also communicates with the inside of the movablemember 3 via a cutout 38. Further, once the attachment X is attached tothe body fluid sampling device Y, the connecting pins 61 make contactwith the reaction electrode 55 and the pairing electrode 56 of thebiosensor 5. Since the connecting pins 61 are urged downward forvertical movement, when the movable member 3 moves vertically, connectorpins 61 also move vertically, maintaining connections with the reactionelectrode 55 and the pairing electrode 56.

[0059] The body fluid sampling device Y incorporates a pusher 63 whichcan be moved downward. The pusher 63 can be moved in different method:For example, the pusher 63 may be latched under a downward urge so thatthe latch may be released by pushing a button. The urging of the pusher63 can be provided by an elastic member such as a coil spring and foamedresin. Of course the pusher 63 may be moved by an electromagneticmethod: Specifically, the pusher 63 or a member to move therewith isprovided with a magnet, and an electric magnet is faced to the magnet.According to this arrangement, pressing of the button causes a repellingforce between the magnet and the electric magnet to move the pusher 63downward. Alternatively, a suction pump may be used to move the pusher63 pneumatically.

[0060] When lancing, as shown in FIG. 10A, the tip of the body fluidsampling device Y is contacted onto a lancing point or skin surface Sk.In this step, the tip of the body fluid sampling device Y may be rubbedagainst or pressed strongly onto the skin surface Sk in order to promotebleeding upon lancing. Of course the gap 65 and the cutouts 38 may beused to generate a partial vacuum in the movable member 3. During this,if the skin surface Sk is sucked upward, the skin surface Sk contactsthe biosensor 5 (See FIG. 10B). Since the movable member 3 is movablerelatively to the holder 2, the movable member 3 moves vertically inaccordance with the bulge of the skin surface Sk while maintainingcontact with the skin surface Sk. As a result, bleeding can be reliablypromoted according to the attachment X, differing from cases where thebiosensor is totally immovable.

[0061] When lancing, the pusher 63 provides a pressing force to thelancing member 21, causing the lancing member 21 to move downward. Whenthe pusher 63 moves downward, as shown in FIG. 10B, the pusher 63interferes with the upper end of the lancing member 21, giving apressing force to the lancing member 21. This pressing force cuts thebrim 29 of the lancing member 21 off the main body 20, moving thelancing member 21 downward, independently from the main body 20. Asshown in FIG. 10C, the lancing needle 28 breaks the seal 26, and movesthrough the through hole 39 of the movable member 3. Then, as shown inFIG. 10D, the lancing needle 28 sticks into the lancing point, causingthe body fluid to bleed from the skin surface Sk.

[0062] As shown in FIG. 11, blood B1 from the skin surface Sk collectsin the recess 5A of the biosensor 5, and then flows to the channel 5B(See FIG. 8). In the reagent layer 57 (See FIG. 6), theoxidation-reduction enzyme promotes an oxidation-reduction reactionbetween blood glucose and the electron transfer material, in which theelectron transfer material is chemically reduced. The reagent layer 57is applied with a voltage via the connecting pins 61 (See FIG. 8), thereaction electrode 55 and the pairing electrode 56 (See FIG. 5 and FIG.6). The voltage oxidizes the electron transfer material. Concomitantly,the body fluid sampling device Y makes measurements via the connectorpins (See FIG. 8), of the electrons released during the oxidationprocess of the electron transfer material, in the form of oxidationcurrent. Based on this oxidation current, a blood glucose level iscalculated.

[0063] The present invention is not limited to the embodiment describedhere above. For example, the technical idea of the present invention isapplicable generally to attachments for concentration level measuringdevices which perform lancing and measuring simultaneously. For exampletherefore, the technical idea of the present invention is applicable tocholesterol level testers and lactic acid level testers which use enzymereactions. Further, the technical idea of the present invention isapplicable to attachments for lancing devices which are intended solelyfor lancing operation.

[0064] Different designs may be used for giving a pressing force to thelancing member. For example, the attachment may be integrated with amoving member serving as a pusher, and the moving member may be movedtoward the skin surface so that the skin surface is hit by theattachment and an impact from the hit serves as the pressing force ontothe lancing member to achieve the lancing.

[0065] A cap may not necessarily be used for assembling the biosensorinto the movable member.

1. An attachment for body fluid sampling device, comprising: a lancingmember including a lancing needle; an analyzing implement for obtaininginformation on a target component in body fluid; and an attachment mainbody holding the lancing member and the analyzing implement, wherein theattachment main body includes a movable member movable with theanalyzing implement longitudinally of the lancing needle.
 2. Theattachment according to claim 1, wherein the attachment main bodyincludes a holder for holding the lancing member, the holder having aninner space for movement of the lancing member, the lancing needle beingheld as sealed in the inner space.
 3. The attachment according to claim2, wherein the holder includes an opening for the inner space tocommunicate with outside, the inner space being sealed by a seal on theopening.
 4. The attachment according to claim 1, further comprising acap co-holding the analyzing implement with the movable member, whereinremoval of the cap leaves the analyzing implement held by the movablemember.
 5. The attachment according to claim 4, wherein the movablemember includes first holding means for holding the analyzing implement,the cap including second holding means for holding the analyzingimplement, the first holding means having a greater holding force forholding the analyzing implement than the second holding means.
 6. Theattachment according to claim 5, wherein the first holding means has aplurality of hook-like engagers.
 7. The attachment according to claim 5,wherein the analyzing implement includes a through hole, the secondholding means includes an engager having a diameter grater than that ofthe through hole, for insertion through the through hole.
 8. Theattachment according to claim 1, wherein the analyzing implementincludes a substrate, and a first and a second electrodes formed on thesubstrate, the analyzing implement being held by the movable member,with part of the first and the second electrodes extending sideways ofthe movable member.
 9. The attachment according to claim 1, wherein thelancing member is integral with the holder via a weak portion, thelancing member moves relatively to the holder upon a longitudinal loadonto the lancing member.
 10. A method of making an attachment for bodyfluid sampling device, comprising: a sealing step of sealing a lancingneedle held by an attachment main body; a sterilizing step ofsterilizing the attachment main body which holds the lancing needle; andan analyzing implement mounting step of mounting an analyzing implementin the sterilized attachment main body.
 11. The method according toclaim 10, wherein the analyzing implement mounting step is performed byattaching a cap which holds the analyzing implement to the attachmentmain body.
 12. The method according to claim 10, wherein the attachmentmain body includes an inner space communicating with outside via anopening, the sealing step being performed by sealing the opening with aseal.
 13. The method according to claim 12, wherein the seal is fixed tothe attachment main body by ultrasonic fusing in the sealing step. 14.The method according to claim 10, wherein the sealing step includesformation of a holder holding the lancing needle, and integrationthereafter of the holder with a movable member, the movable memberhaving holding means for holding the analyzing implement and beingmovable back and forth relatively to the holder.